Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dose

Cardiac toxicity may also occur at lower cumulative doses (400 mg/m2) in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphamide therapy

Acute infusion-related reactions including, but not limited to, flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or hypotension have occurred in up to 10% of patients treated with DOXIL. In most patients, these reactions have resolved within several hours to a day once the infusion is terminated. In some patients, reactions resolved with slowing of the infusion rate

Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have occurred. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use

The initial rate of infusion should be 1 mg/min to minimize the risk of infusion reactions

Severe myelosuppression may occur

DOXIL dosage should be reduced in patients with impaired hepatic function

Accidental substitution has resulted in severe side effects. Do not substitute for doxorubicin HCl on a mg per mg basis

Contraindications

Patients with a history of hypersensitivity reactions to a conventional doxorubicin formulation or the components of DOXIL

Nursing mothers

Additional Safety Information

Cardiac function should be carefully monitored

Congestive heart failure or cardiomyopathy may occur after discontinuation of anthracycline therapy

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